Clearance Summary
ShefaBone SCPC Resorbable Bone Graft received FDA 510(k) clearance under submission number K153230, sponsored by The Implantech Inc./Shefabone. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2016-07-14.
- Submission: K153230
- Applicant / Sponsor: The Implantech Inc./Shefabone
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2016-07-14
Classification & Regulation
This clearance is catalogued under FDA product code LYC and 21 CFR 872.3930, within the Dental review panel as a Class II device.